Back to resultsA Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
Primary Purpose
Panic Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sertraline and Alprazolam XR
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder
Eligibility Criteria
Inclusion Criteria: Subjects will include men and women over the age of eighteen; the ability to give written informed consent; current principal or co-principal psychiatric diagnosis of panic disorder with or without agoraphobia based on DSM-IV criteria (American Psychiatric Association, 1994); willing to use an effective means of contraception; free of psychoactive medications for at least 2 weeks prior to study enrollment; not actively be suicidal. Exclusion Criteria: actively suicidal; medical conditions for which either sertraline or alprazolam XR would be contraindicated; recent six month history of substance or alcohol abuse; history or presence of psychotic or bipolar disorder; women who are pregnant or breastfeeding; history or presence of a seizure disorder or a known history of more than one childhood febrile seizure; presence of a personality disorder severe enough to compromise the investigator's ability to evaluate the efficacy and safety of the study medication; concomitant therapy with other psychotropic medication(s); clinically significant abnormality during physical examination, vital signs, EKG, urine drug screen, or laboratory tests at the screen visit.
Sites / Locations
- University of South Florida, Department of Psychiatry and Behavioral Medicine
- University Hospital Outpatient Center, Psychiatry
- University of Pennsylvania, Mood and Anxiety Disorders Section
Outcomes
Primary Outcome Measures
Panic symptoms scale score
CGI-I
CGI-S
Secondary Outcome Measures
Sheehan Disability Scale
Full Information
NCT ID
NCT00198094
First Posted
September 12, 2005
Last Updated
October 19, 2007
Sponsor
Indiana University School of Medicine
Collaborators
Pfizer, University of Pennsylvania, University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT00198094
Brief Title
A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
Official Title
A Randomized Double-Blind Comparison of Sertraline With Early Alprazolam XR Co-Administration vs Sertraline/Placebo for Primary Care Panic Disorder Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Indiana University School of Medicine
Collaborators
Pfizer, University of Pennsylvania, University of South Florida
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sertraline and Alprazolam XR
Primary Outcome Measure Information:
Title
Panic symptoms scale score
Title
CGI-I
Title
CGI-S
Secondary Outcome Measure Information:
Title
Sheehan Disability Scale
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will include men and women over the age of eighteen;
the ability to give written informed consent;
current principal or co-principal psychiatric diagnosis of panic disorder with or without agoraphobia based on DSM-IV criteria (American Psychiatric Association, 1994);
willing to use an effective means of contraception;
free of psychoactive medications for at least 2 weeks prior to study enrollment;
not actively be suicidal.
Exclusion Criteria:
actively suicidal;
medical conditions for which either sertraline or alprazolam XR would be contraindicated;
recent six month history of substance or alcohol abuse;
history or presence of psychotic or bipolar disorder;
women who are pregnant or breastfeeding;
history or presence of a seizure disorder or a known history of more than one childhood febrile seizure;
presence of a personality disorder severe enough to compromise the investigator's ability to evaluate the efficacy and safety of the study medication;
concomitant therapy with other psychotropic medication(s);
clinically significant abnormality during physical examination, vital signs, EKG, urine drug screen, or laboratory tests at the screen visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew W Goddard, M.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl Rickles, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Sheehan, M.D., M.B.A.
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida, Department of Psychiatry and Behavioral Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
University Hospital Outpatient Center, Psychiatry
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Pennsylvania, Mood and Anxiety Disorders Section
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-3309
Country
United States
12. IPD Sharing Statement
Citations:
Citation
A randomized double-blind comparison of sertraline with early alprazolam XR Co-administration vs. sertraline/placebo for panic disorder. Goddard AW, Ball SG, Hastings AK, Shekhar A, Rickels K, Rynn M, Janavs J, Sheehan DV. BIOLOGICAL PSYCHIATRY 57 (8): 62S-62S 220 Suppl. S, APR 15 2005. IDS Number: 915VE ISSN: 0006-3223
Results Reference
result
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A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
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